In order to adequately monitor a clinical trial, the monitor must be familiar with each of the following, EXCEPT the:
Answer(s): D
Monitors verify compliance with protocol, sponsor SOPs, GCP, and regulations.ICH E6(R2) 5.18.4: Outlines monitor responsibilities, including verifying informed consent, protocol compliance, investigational product accountability, and adherence to sponsor SOPs.Monitors must also be familiar with subject-facing documents (A) and storage requirements for investigational product (B).However, IRB/IEC requirements for reporting to regulatory authorities are outside a monitor's scope. That responsibility lies with investigators and IRBs under 21 CFR 56.108(b).Thus, the correct answer is D.
ICH E6(R2), §5.18.4.21 CFR 56.108(b).
In accordance with ICH/GCP Guidance, how long should an IRB/IEC retain all relevant study-related records pertaining to the IRB/IEC's review after a trial has been completed?
Answer(s): A
IRBs/IECs must retain records to permit evaluation of compliance.ICH E6(R2) 3.4.2: "IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for at least 3 years after completion of the trial."Extended retention (BD) may occur institutionally, but ICH minimum is 3 years.Correct answer: A (At least 3 years).
ICH E6(R2), §3.4.2.
During an audit of a sponsor, the following documents and activities were reviewed: the protocol, applicable regulatory requirements, and compliance with Good Clinical Practice (GCP). What additional documents must be reviewed during the sponsor audit?
Sponsor audits ensure systems comply with GCP.ICH E6(R2) 5.19.3: "The sponsor's auditing procedures should include a review of quality assurance audits and audit reports."Audit reports document findings from independent evaluations and are essential for ensuring compliance.SOPs (A) are reviewed during audits but are not mandated as standalone "audit review documents." Personnel files (B) and financial reports (C) are not required under GCP auditing provisions.Correct answer: D (Audit reports).
ICH E6(R2), §5.19.3.
A study team is preparing to initiate a Phase II trial for a novel colon cancer therapy. By signing the Form FDA 1572, the investigator is certifying that the investigator has:
Form FDA 1572 is the "Statement of Investigator" for IND studies.21 CFR 312.53(c)(1)(vi)(b): Requires investigators to "read and understand the Investigator's Brochure."By signing, the investigator also agrees to comply with regulations, maintain records, and supervise study conduct.Other options (BD) are not part of 1572 requirements.Correct answer: A.
21 CFR 312.53(c)(1)(vi)(b).
In accordance with the ICH GCP Guideline, who is responsible for the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the case report forms and in all required reports?
The investigator holds ultimate responsibility for all data reported.ICH E6(R2) 4.9.1: "The investigator is responsible for the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor on the CRFs and all required reports."Monitors (D) verify data accuracy but are not responsible for data quality. Quality specialists (B) and IRB staff (C) have no role in data entry.Correct answer: A (The clinical investigator).
ICH E6(R2), §4.9.1.
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